Stimulus-Stimulus Pairing Study

NCT02464527 | Completed

• 1 other identifier: IRB00073588
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current study is to deliver the SSP procedure to children diagnosed with autism that do not have vocal language. The study will also aim to gather data in the natural environment using a voice recorder.

Conditions

Autism Spectrum Disorder

Keywords

Stimulus-stimulus pairing

Outcome Measures

Primary Outcomes (5)

• Feasibility of intervention assessed by a change in frequency of target vocalizations and/or approximations during sessions

  The therapist will pair echoic sounds and words with preferred items. A target vocalization is any vocal response that matches the paired sound or word. An approximation is any sound that is a component of the targeted word. A successful vocalization is when the participant emits the target or approximation of a targeted sound or word. Change is defined as the difference in the number of vocalizations at week 1 and week 6.

  Week 1, Week 6

• Change in frequency of target vocalizations and/or approximations at home

  Vocalization data will be collected in the home via the vocal recorder device. Target vocalization is when the participant emits the target sound or word. An approximation is any sound that is a component of the targeted word. Change is defined as the difference in the number of vocalizations at week 1 and week 6.

  Week 1, Week 6

• Change in parent-reported vocalizations

  A parent-rated checklist will assess their child's vocal language and parents will rate improvement as a yes or no question on the checklist at week 1 and week 6.

  Week 1, Week 6

• Feasibility of intervention assessed by reliability of delivery by therapists

  The number of times stimulus-stimulus pairing (SSP) is reliably delivered by the therapist to the participant during the treatment period of 6 weeks will be assessed. Reliable delivery consists of the therapist pairing sounds and words with preferred items in accordance to the protocol.

  Week 6

• Acceptability of stimulus-stimulus pairing (SSP) by parents

  The level of compliance and willingness of the parents/guardian to bring the subjects to the treatment sessions will be assessed. Acceptability is when the parent/guardian brings the subject to the clinic for the treatment sessions for one hour a day, five days per week, for 6 weeks.

  Week 6

Secondary Outcomes (2)

• Feasibility of intervention assessed by compliance of the vocal recorder

  Week 6

• Feasibility of the vocal recorder assessed by the utility of vocal recorder

  Week 6

Study Arms (2)

Stimulus-stimulus pairing (SSP)

EXPERIMENTAL

Minimally verbal children between 2.0 and 3.9 years with autism spectrum disorder (ASD) and who do not emit vocalizations, will be randomly assigned to the treatment group and will begin the stimulus-stimulus pairing (SSP) procedure. Subjects will be recorded by a vocal recorder at home by the parent/guardian at home or in the community setting.

Behavioral: Stimulus-stimulus pairing; Other: Vocal recorder

Waitlist Control (Delayed Treatment)

ACTIVE COMPARATOR

Minimally verbal children between 2.0 and 3.9 years with autism spectrum disorder (ASD) and who do not emit vocalizations will be randomly assigned to the Waitlist Control group. During the waitlist control subject's assigned session block of six weeks, s/he will not receive any treatment. The subjects will receive the stimulus-stimulus pairing procedure (delayed procedure) after the completion of the assigned 6-week block as a waitlist control participant. Subjects will be recorded by a vocal recorder at home by the parent/guardian at home or in the community setting.

Behavioral: Stimulus-stimulus pairing; Other: Vocal recorder

Interventions

Stimulus-stimulus pairing BEHAVIORAL

The participants will attend clinic-based treatment sessions for one hour per day, five days per week, for 6-weeks.The stimulus-stimulus pairing procedure will consist of sounds and words being systematically paired with delivery of a preferred item.

Stimulus-stimulus pairing (SSP); Waitlist Control (Delayed Treatment)

Vocal recorder OTHER

The vocal recorder is a voice recording device that enhances vocalization data. The parent/ guardian will be instructed on how to use the vocal recorder. The vocal recorder will then be deployed at the participant's homes via parent/guardian. The parent/guardian will record vocalizations for approximately 1 hour while in the home or community setting pre, mid, and post treatment. The parent/guardian will return the vocal recorder to the study team for analysis of the recordings.

Stimulus-stimulus pairing (SSP); Waitlist Control (Delayed Treatment)

Eligibility Criteria

• Age: 24 Months - 47 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of autism
• Currently do not emit vocalizations or minimally verbal
• Willingness of the participant's parent/guardian to bring their child to the Marcus Autism Center for one-hour appointments, five days a week, for six weeks.

You may not qualify if:

• \. Children with significant problem behavior that interferes with structured intervention

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Alice Shillingsburg, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: June 8, 2015
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 15, 2016

Record last verified: 2016-07

Locations

US (1)